|
Device | Activa® Deep Brain Stimulation Therapy System, Percept™ PC BrainSense™ |
Generic Name | Stimulator, electrical, implanted, for parkinsonian tremor |
Applicant | MEDTRONIC Inc. 7000 CENTRAL AVENUE NE MINNEAPOLIS, MN 55432-3576 |
PMA Number | P960009 |
Supplement Number | S454 |
Date Received | 06/02/2023 |
Decision Date | 07/20/2023 |
Product Code |
MHY |
Advisory Committee |
Neurology |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for change in maximum length of the Proximal Body Assemblys distance between the connectorring flange to the proximal reflow joint between the connector and lead body tubing from 0.180 inches to 0.193 inches. |